Boehringer Ingelheim Submits Marketing Authorisation Application to European Union and to the FDA for Investigational Anti-HIV Agent Tipranavir

25.10.2004 – 08:05

Ingelheim, Germany (ots/PRNewswire) - Boehringer Ingelheim today
announced the submission of a Marketing Authorisation Application
(MAA) to the European Medicines Agency (EMEA) for tipranavir.
Simultaneously the documentation was submitted to the FDA.

Tipranavir is a non-peptidic protease inhibitor (NPPI) for the
treatment of HIV-1 infection in combination with other antiretroviral
agents in patients who are protease inhibitor experienced. The
application is supported by data from Phase II and Phase III studies
of tipranavir boosted with low-dose ritonavir (tipranavir/r) in more
than 2500 patients worldwide.

Two large-scale Phase III clinical trials, RESIST-1 and
RESIST-2(i) form the foundation of the MAA for tipranavir. These
studies were randomized, controlled, open-label trials designed to
examine the safety and efficacy of tipranavir/r versus a low-dose
ritonavir-boosted comparator protease inhibitor in
treatment-experienced patients. Interim data from RESIST-1 will be
presented at the 44th Interscience Conference on Antimicrobial Agents
and Chemotherapy in Washington, DC this week.(1) Results from this
study show that tipranavir is a viable treatment option for patients
who have failed other protease inhibitors.

"Boehringer Ingelheim is committed to the development of new
therapies that will benefit people living with HIV/AIDS," said Dr.
Andreas Barner, Vice-Chairman of the Board of Managing Directors and
Head of Corporate Board Division Pharma Research, Development and
Medicine at Boehringer Ingelheim. "The submission for tipranavir
brings us one step closer to providing a potent treatment when the HI
virus has developed resistance to most commercially available
protease inhibitors."

Tipranavir

Tipranavir is a non-peptidic protease inhibitor currently in Phase
III of clinical development. In June 2004, Boehringer Ingelheim
announced the enrollment of the first patient in a broad-scale global
tipranavir Compassionate Use Program, which provides access to
HIV-positive patients in desperate clinical need of new treatment
options.

Tipranavir is also being evaluated for use in pediatric and
treatment-naive patient populations. Pivotal clinical studies are
currently underway.

Based on available clinical and in vitro data, tipranavir is
active against most strains of HIV-1 that are resistant to
commercially available protease inhibitors. Ongoing studies are
designed to confirm these data.

In studies to date, tipranavir has been well tolerated by most
patients and has a safety profile similar to other PIs. The most
commonly reported adverse events across all clinical trials were
gastrointestinal-related and included diarrhea, nausea, fatigue,
headache and vomiting. Consistent with other PIs, the most common
laboratory abnormalities were elevated liver enzymes and
triglycerides.

Boehringer Ingelheim

Boehringer Ingelheim is committed to the research and development
of novel antiretroviral agents. Viramune(R) (nevirapine) is a product
of original research done at Boehringer Ingelheim. Viramune(R) was
the first member of the non-nucleoside reverse transcriptase
inhibitor (NNRTI) class of anti-HIV drugs. Boehringer Ingelheim is
committed to the rapid development of the investigational
non-peptidic protease inhibitor (NPPI) tipranavir in phase III
clinical trials and recently acquired the nucleoside analogue (NRTI)
MIV-310 currently in phase II development. The company is involved in
basic research and is committed to improving HIV therapy by providing
physicians and patients with innovative antiretrovirals.